Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries

This study has been terminated.
(no interest to develop the product)
Sponsor:
Information provided by:
Ovalum
ClinicalTrials.gov Identifier:
NCT00733070
First received: August 10, 2008
Last updated: July 6, 2013
Last verified: July 2013
  Purpose

A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.


Condition Intervention
Coronary Chronic Total Occlusion
Device: CiTop™ ExPander™ Guidewire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Multinational Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries

Further study details as provided by Ovalum:

Primary Outcome Measures:
  • Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications [ Time Frame: during procedure, 1day, 1week and 30 days post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Successful stenting [ Time Frame: During procedure, Day1, Day7 and Day30 post procedure ] [ Designated as safety issue: Yes ]
  • Wire crossing duration [ Time Frame: during procedure ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • Amount of contrast [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • Maneuverability of the CiTop™ up to the occlusion [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • No mechanical damage to the device during [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CiTop™ ExPander™ Guidewire
    Chronic Total Occlusion guidewire
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent obtained prior to any trial activities.
  2. Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
  3. Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.

Exclusion Criteria:

  1. Patient unable to give informed consent.
  2. Current participation in another study with any investigational drug or device.
  3. Factors making follow-up and/or repeat angiography difficult or unlikely.
  4. Contra-indication to emergency artery by pass surgery.
  5. Lack of surgical backup.
  6. Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
  7. Lesion > 40mm in length (both calcified lesion and adjacent thrombus).
  8. Treated vessel referenced diameter less than 2.5 mm.
  9. Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
  10. Non-visible entry point of target lesion.
  11. Totally occluded bypass graft as target vessel.
  12. Acute MI less than 1 week before procedure.
  13. Patient has significant LV dysfunction, 35% LVEF or less.
  14. Patient with cancer or other sever chronic disease with life expectance of 2 years.
  15. Patient has chronic renal failure with serum creatinine ≥2.
  16. Hemoglobin ≤11.
  17. Patient is known or suspected not to tolerate the contrast agent.
  18. Morbid Obesity (BMI > 40).
  19. Drug abuse or alcoholism.
  20. Patients under custodial care.
  21. Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733070

Locations
Germany
HELIOS Klinikum Wuppertal
Wuppertal, Germany, D-42117
South Africa
Sunward Park Hospital
Boksburg, South Africa
Sunninghill Hospital
Sunninghill, South Africa, 2157
Sponsors and Collaborators
Ovalum
  More Information

No publications provided

Responsible Party: Nathalie Gilat, Ovalum
ClinicalTrials.gov Identifier: NCT00733070     History of Changes
Other Study ID Numbers: OVC-003-00
Study First Received: August 10, 2008
Last Updated: July 6, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Ovalum:
CTO
Chronic Total Occlusion
Revascularization

ClinicalTrials.gov processed this record on July 24, 2014